Thoracic Injuries Clinical Trial
Official title:
A Comparison of Positional Stability: the EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery
Verified date | June 2019 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the positional stability and quality of lung isolation provided by the EZ-blocker compared to a DLT for both right and left sided thoracic surgery. An additional objective will be to assess time to placement of both devices and other significant clinical differences between these two approaches to placement of the bronchial blocker (BB) including airway injury and post-operatives sore throat, post-operative hoarseness, Additionally we would like to examine the preoperative high resolution CT imaging data to determine if there are anatomic landmarks that may potentially inform the appropriateness or inappropriateness of choosing an EZ-blocker or left sided DLT.
Status | Completed |
Enrollment | 163 |
Est. completion date | October 29, 2019 |
Est. primary completion date | October 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients greater than 18 and 80 years of age scheduled for thoracoscopic surgery or thoracotomy requiring lung isolation - Patient presenting as an outpatient for elective thoracic surgery - In patients scheduled for thoracic surgery. Exclusion Criteria: - History of difficult airway/intubation - Patients suspected to have a difficult airway. - Morbid obesity BMI >39 - Pregnancy - Emergency status of surgery - Thoracic surgery requiring a right sided double lumen tube |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Hospital | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Campos JH, Hallam EA, Van Natta T, Kernstine KH. Devices for lung isolation used by anesthesiologists with limited thoracic experience: comparison of double-lumen endotracheal tube, Univent torque control blocker, and Arndt wire-guided endobronchial blocker. Anesthesiology. 2006 Feb;104(2):261-6, discussion 5A. — View Citation
Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2. Review. — View Citation
Dumans-Nizard V, Liu N, Laloë PA, Fischler M. A comparison of the deflecting-tip bronchial blocker with a wire-guided blocker or left-sided double-lumen tube. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):501-5. doi: 10.1053/j.jvca.2009.02.002. Epub 2009 Apr 10. — View Citation
Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. — View Citation
Kus A, Hosten T, Gurkan Y, Gul Akgul A, Solak M, Toker K. A comparison of the EZ-Blocker with a Cohen Flex-Tip blocker for one-lung ventilation. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):896-9. doi: 10.1053/j.jvca.2013.02.006. Epub 2013 Aug 16. — View Citation
Mourisse J, Liesveld J, Verhagen A, van Rooij G, van der Heide S, Schuurbiers-Siebers O, Van der Heijden E. Efficiency, efficacy, and safety of EZ-blocker compared with left-sided double-lumen tube for one-lung ventilation. Anesthesiology. 2013 Mar;118(3):550-61. doi: 10.1097/ALN.0b013e3182834f2d. — View Citation
Mungroop HE, Wai PT, Morei MN, Loef BG, Epema AH. Lung isolation with a new Y-shaped endobronchial blocking device, the EZ-Blocker. Br J Anaesth. 2010 Jan;104(1):119-20. doi: 10.1093/bja/aep353. — View Citation
Piccioni F, Vecchi I, Spinelli E, Previtali P, Langer M. Extraluminal EZ-blocker Placement for One-lung Ventilation in Pediatric Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):e71-3. doi: 10.1053/j.jvca.2015.05.200. Epub 2015 May 27. — View Citation
Templeton TW, Downard MG, Simpson CR, Zeller KA, Templeton LB, Bryan YF. Bending the rules: a novel approach to placement and retrospective experience with the 5 French Arndt endobronchial blocker in children <2 years. Paediatr Anaesth. 2016 May;26(5):512-20. doi: 10.1111/pan.12882. Epub 2016 Mar 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements | Positional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung. | End of surgical procedure | |
Secondary | Time it Takes to Place for Double Lumen Tube (DLT) and EZ | Time of placement for both devices | End of surgical procedure | |
Secondary | Quality of Lung Isolation Between Devices | Measured at 1 hour intervals during operation on a scale of 1-3 with 1 being Excellent, 2 being Fair, and 3 being Poor. | End of surgical procedure | |
Secondary | Side Effects of Devices | Sore throat/hoarseness postoperatively on a scale of 0-100 with 0 being No Sore Throat and 100 being Worst Sore Throat Imaginable. | 2 days post operation |
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